NCT04594239

Brief Summary

  • Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control.
  • Confirm the safety of BBL injection for the correction of volume loss in the IOH area.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

October 13, 2020

Results QC Date

October 27, 2023

Last Update Submit

January 23, 2024

Conditions

Volume Loss in the Infraorbital Hollow Area

Outcome Measures

Primary Outcomes (1)

  • Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8

    Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (\>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach.

    Week 8

Secondary Outcomes (5)

  • Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator

    Week 8

  • Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject

    Week 8

  • Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8

    Baseline, Week 8

  • Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL

    BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks

  • Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL

    BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks

Study Arms (4)

Treatment, needle

EXPERIMENTAL
Device: Belotero Balance (+) Lidocaine, needle

Treatment, cannula

EXPERIMENTAL
Device: Belotero Balance (+) Lidocaine, cannula

Untreated-control / delayed-treatment, needle

OTHER
Device: Untreated-control / delayed-treatment, needle

Untreated-control / delayed-treatment, cannula

OTHER
Device: Untreated-control / delayed-treatment, cannulas

Interventions

Belotero Balance (+) Lidocaine, needleDEVICE

Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles

Treatment, needle
Belotero Balance (+) Lidocaine, cannulaDEVICE

Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas

Treatment, cannula
Untreated-control / delayed-treatment, needleDEVICE

Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)

Untreated-control / delayed-treatment, needle
Untreated-control / delayed-treatment, cannulasDEVICE

Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)

Untreated-control / delayed-treatment, cannula

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is a candidate for bilateral IOH treatment.
  • Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.

You may not qualify if:

  • Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
  • Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
  • Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
  • Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Art of Skin MD, Merz Investigational Site #0010444

Solana Beach, California, 92075, United States

Location

Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358

Vista, California, 92083, United States

Location

MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446

Atlanta, Georgia, 30342, United States

Location

Project Glammers, Merz Investigational Site #0010443

Brooklyn, New York, 11229, United States

Location

The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442

Mount Kisco, New York, 10549, United States

Location

Mariwalla Dermatology, Merz Investigational Site #0010445

West Islip, New York, 11795, United States

Location

HKB Surgeons, Merz Investigational Site #0010447

Huntersville, North Carolina, 28078, United States

Location

Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353

Nashville, Tennessee, 37203, United States

Location

Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436

San Juan, 00917, Puerto Rico

Location

MeSH Terms

Interventions

NeedlesCannulaTreatment Delay

Intervention Hierarchy (Ancestors)

Equipment and SuppliesCathetersTime-to-TreatmentPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Public Disclosure Manager
Organization
Merz Aesthetics
Aesthetic.Trials@merz.com
+1 984-301-3095

Study Officials

  • Merz Medical Expert

    Merz North America, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

August 31, 2020

Primary Completion

April 8, 2021

Study Completion

June 21, 2022

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PR(1)US(8)